雷帕霉素药物洗脱支架的生物安全性评价  

The Biological Safety Evaluation of Rapamycin Drug-eluting Stent

作　　者：陈斌[1] 祝君梅[1] 程鹏[1] 程琳[1] 李毅敏[1] 

机构地区：[1]天津市医药科学研究所 天津市医用生物材料监测中心,天津300020

出　　处：《生物医学工程研究》2014年第1期52-55,共4页Journal Of Biomedical Engineering Research

摘　　要：评价雷帕霉素药物洗脱支架的生物安全性。依据国家标准GB/T16886,通过10项试验,对此材料进行生物学安全性评价。试样无溶血性、急性全身毒型、细胞毒性、遗传毒性、致敏性,皮内刺激试验中无刺激性。在肌肉植入试验中,植入后1、4和12周对局部组织轻度刺激,26周无刺激作用。亚慢性全身毒性试验发现有给药相关的肝毒性、心毒性、免疫毒性和脂代谢异常。亚慢性全身毒性采用的给药方法可能并不适用于此类材料,方案需要进一步调整。其余试验中生物相容性尚可。To evaluate the biological safety of Rapamycin drug-eluting stent. 10 experiments were conducted to evaluate biological safety according to the national standard GB / T16886. There was no hemolysis,systemic acute toxicity,cytotoxicity,genotoxicity,or intracutaneous irritation. The result of muscle implant test showed that the samples had local tissue mild irritation on 1,4 and 12 weeks after implantation,and no irritation on 26 weeks. The drug-related hepatotoxicity,cardiotoxic,immune toxicity and abnormal lipid metabolism were found in sub-chronic systemic toxicity. The medication of sub-chronic systemic toxicity test may not be applicable to such materials. The programs should be further adjusted. The samples possess biological safety in other tests.

关 键 词：生物安全性 医疗器械 雷帕霉素 全身毒性 肌肉植入试验 

分 类 号：R318[医药卫生—生物医学工程]